FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- resistance to conservative treatment
Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty

Device Description

The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.

AI/ML Overview

This submission describes a medical device, the Avanta Orthopaedics Radial Head Implant, and seeks to establish its substantial equivalence to a legally marketed predicate device, the Wright Medical Swanson Titanium Radial Head Implant. It is not a study proving device meets acceptance criteria in the traditional sense of a clinical trial or performance study against pre-defined statistical endpoints for a novel device. Instead, the submission argues for substantial equivalence based on similarities in design, materials, and intended use to a device already on the market.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly stated in this type of 510(k) submission. However, I will extract and infer information where possible based on the provided text.

Here’s the information based on the provided 510(k) summary:

A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not performance metrics in the typical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are satisfied by demonstrating the new device is sufficiently similar to the predicate device in terms of design, materials, and intended use, such that it raises no new questions of safety or effectiveness. The reported "performance" is the comparison against the predicate.

Item	Acceptance Criteria (Similarity to Predicate)	Reported Device Performance (Avanta Product)
Product Name	Similar type of implant functionality	Radial Head Implant
Use	Single use	Single use
Fixation	Stem in intramedullary canal	Stem in intramedullary canal
Constraint	Non-constrained	Non-constrained
Material	Industry standard materials	Co-Cr/CpTi (predicate is Titanium)
Sizes	Comparably sized	3 sizes (1, 2, 3) (predicate has 5 sizes)
Indications for Use	Same indications for use	Same as predicate

Conclusion of Performance: The submission states, "The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device." This indicates the device met the acceptance criteria for substantial equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a submission for substantial equivalence based on design and material comparison to a predicate device, not a performance study involving a test set of patient data. There is no mention of a test set, patient data, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the existing predicate device and comparison by regulatory bodies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set. The "adjudication" for substantial equivalence is carried out by the FDA during its review process.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/imaging device, nor is it a comparative effectiveness study involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable to a conventional performance study. For substantial equivalence, the "ground truth" is effectively the regulatory approval and established safety and efficacy profile of the predicate device (Swanson Titanium Radial Head Implant), which has been marketed since 1994. The Avanta device is deemed safe and effective because it is substantially equivalent to the predicate.
The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning or diagnostic device performance study.
How the ground truth for the training set was established

Not applicable. No training set.

Summary

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.